Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Melanoma

Skin Neoplasms

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Temozolomide

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.

Combination chemotherapy was administered for up to 6 cycles

Paclitaxel, carboplatin, temozolomide

Montasur Shaheen, MD

The number of melanoma cases has been steadily increasing over the past few decades. For many patients with metastatic melanoma, there are no effective therapies. The goal of this study is to determine whether a combination drug treatment of carboplatin, paclitaxel and temozolomide is effective in the treatment of metastatic or recurrent melanoma.

Over the past several decades, significant research has been conducted to try to identify active chemotherapeutic agents for the treatment of melanoma. The rationale for combining taxanes and platinum agents is that both have activity in melanoma; in vitro and clinical data suggest synergy between these drugs when used in combination in a wide variety of tumors, including melanoma; and the toxicity profiles of these agents do not overlap. Temozolomide (a drug approved for the treatment of melanoma) has been combined with other drugs, including taxanes and platinums, in previous clinical trials for melanoma. Specifically, a previous phase I study of the combination of temozolomide, paclitaxel, and carboplatin in melanoma showed objective responses. The efficacy of this combination is now being studied in this phase II trial.

Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Phase II Trial of Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam and/or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. The Objective Response Rate (ORR) is the sum of the percentages of patients achieving CR or PR.

The time from treatment initiation to death by any cause.

All toxicities encountered during the study by patients who receive at least one on-study treatment will be graded according to the NCI CTCAE (Version 3.0). The number of patients experiencing adverse events will be reported according to grade.

The time from treatment initiation to disease progression or death by any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by physical exam or computerized tomography (CT): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

New Mexico Cancer Care Alliance

Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.

Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles

Chemotherapy Combination

Age, Categorical

Sex: Female, Male

White non-Hispanic

White Hispanic

Black

Race/Ethnicity, Customized

United States

Region of Enrollment

Brain

Bone

Liver

Lung

Other visceral organs

Regional Lymph Nodes

Site of Metastasis

Surgery

Radiation

Chemotherapy

Interferon

Immune Vaccines

Previous Therapy

Montaser Shaheen, MD, PhD

Complete response (CR)

Partial response (PR)

Stable disease

Progressive disease (PD)

ORR (CR + PR)

The 16 patients who completed treatment were evaluable for the endpoint of overall response rate.

Objective Response Rate (ORR)

The 16 patients who completed treatment were evaluable for survival analysis.

Overall Survival

Fatigue (Grade 1-2)

Fatigue (Grade 3-4)

Fever (Grade 1-2)

Fever (Grade 3-4)

Weight loss (Grade 1-2)

Weight loss (Grade 3-4)

Anorexia (Grade 1-2)

Anorexia (Grade 3-4)

Diarrhea (Grade 1-2)

Diarrhea (Grade 3-4)

Aspartate aminotransferase increased (Grade 1-2)

Aspartate aminotransferase increased (Grade 3-4)

Vomiting (Grade 1-2)

Vomiting (Grade 3-4)

Gastrointestinal Bleed (Grade 1-2)

Gastrointestinal Bleed (Grade 3-4)

Nausea (Grade 1-2)

Nausea (Grade 3-4)

Alanine aminotransferase increased (Grade 1-2)

Alanine aminotransferase increased (Grade 3-4)

Hyperbilirubinemia (Grade 1-2)

Hyperbilirubinemia (Grade 3-4)

Neutropenia (Grade 1-2)

Neutropenia (Grade 3-4)

Anemia (Grade 1-2)

Anemia (Grade 3-4)

Lymphopenia (Grade 1-2)

Lymphopenia (Grade 3-4)

Leukopenia (Grade 1-2)

Leukopenia (Grade 3-4)

Thrombocytopenia (Grade 1-2)

Thrombocytopenia (Grade 3-4)

Hyperglycemia (Grade 1-2)

Hyperglycemia (Grade 3-4)

Hypophosphatemia (Grade 1-2)

Hypophosphatemia (Grade 3-4)

Hypokalemia (Grade 1-2)

Hypokalemia (Grade 3-4)

Hyponatremia (Grade 1-2)

Hyponatremia (Grade 3-4)

Chest wall pain (Grade 1-2)

Chest wall pain (Grade 3-4)

Bone pain (Grade 1-2)

Bone pain (Grade 3-4)

Muscle weakness, lower limb (Grade 1-2)

Muscle weakness, lower limb (Grade 3-4)

Joint pain (Grade 1-2)

Joint pain (Grade 3-4)

Drowsiness (Grade 1-2)

Drowsiness (Grade 3-4)

Peripheral Sensory Neuropathy (Grade 1-2)

Peripheral Sensory Neutropenia (Grade 3-4)

Pericardial effusion (Grade 1-2)

Pericardial effusion (Grade 3-4)

Edema limbs (Grade 1-2)

Edema limbs (Grade 3-4)

Alopecia (Grade 1-2)

Alopecia (Grade 3-4)

Rash (Grade 1-2)

Rash (Grade 3-4)

Dry mouth (Grade 1-2)

Dry mouth (Grade 3-4)

All patients who had received at least one dose of on-study treatment were evaluable for toxicity.

Safety Profile

The 16 patients who completed treatment were evaluable for progression-free survival.

Time to Progression

Overall Study

Spots Global Cancer Trial Database for Carboplatin, Paclitaxel, and Temozolomide for Patients With Metastatic Melanoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial